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Public health experts have raised concerns about the ability of the nation's public health system to detect and respond to emerging infectious disease threats, such as pandemic influenza. Although vaccines are considered the first line of defense to prevent or reduce influenza-related illness and death, GAO found that they may be unavailable, in short supply, or ineffective for some portions of the population during the first wave of a pandemic. Federal and state influenza pandemic plans are in various stages of completion and do not completely or consistently address key issues surrounding the purchase, distribution, and administration of vaccines and antiviral drugs. Inconsistencies in state and federal policies could contribute to public confusion and weaken the effectiveness of the public health response.

Recommendations for Executive Action

Status: Closed - Implemented

Comments: In a 2000 report on federal and state response efforts for pandemic influenza, GAO recommended that the Secretary of the Department of Health and Human Services (HHS) establish a deadline for completing and publishing a federal response plan that will address how priorities for receiving limited influenza and pneumococcal vaccines and antiviral drugs during a pandemic will be established among population groups. In response, HHS published its Pandemic Influenza Plan in November 2005. This plan includes a list of recommended priority groups for limited vaccines and antiviral drugs during a pandemic.

Recommendation: The Secretary of Health and Human Services should establish a deadline for completing and publishing a federal response plan that will address how priorities for receiving limited influenza and pneumococcal vaccines and antiviral drugs during a pandemic will be established among population groups.

Agency Affected: Department of Health and Human Services

Status: Closed - Implemented

Comments: In a 2000 report on federal and state response efforts for pandemic influenza, GAO recommended that the Secretary of Health and Human Services (HHS) take steps to fill the knowledge gaps in the capability of the private and public sectors to produce, distribute, and administer vaccines and antiviral drugs to various population groups to control the spread and effect of a pandemic. Specifically, GAO recommended that if existing surge capacity is insufficient, HHS work with manufacturers to determine the investment and time required to expand production capacity, or the feasibility of creating a stockpile against projected shortages. In response, HHS has, in coordination with domestic manufacturers, supported efforts to increase domestic vaccine manufacturing capacity to produce 300 million courses of vaccine within 6 months of development of a vaccine reference strain during a pandemic. HHS, primarily through the Food and Drug Administration, will make recommendations to policymakers for request of contracts to build capacity through the retrofitting of existing FDA-licensed vaccine and biologics manufacturing facilities. HHS will further support the renovation of existing domestic manufacturing facilities that produce other FDA-licenses cell-based vaccines or biologics as well as the establishment of new domestic cell-based influenza vaccine manufacturing facilities. For example, in June 2007, HHS awarded two contracts totaling $132.5 million to retrofit existing domestic vaccine manufacturing facilities, which should expand U.S. manufacturing capacity by 16 percent. In the interim, HHS reported in its November 2006 Pandemic Influenza Implementation Plan that the department will establish and maintain stockpiles of pre-pandemic vaccines adequate to immunize at least 20 million persons against influenza strains that present a pandemic threat. Regarding stockpiling of antiviral drugs, HHS reported in a July 2007 report that the department had purchased a total of 37.4 million treatment courses of antiviral drugs for the federal stockpile over the prior 12 months and that 29.8 million treatment courses had been received by the Strategic National Stockpile.

Recommendation: To improve the nation's ability to respond to the emergence of a pandemic influenza virus and help ensure an adequate and appropriate level of public protection, the Secretary of Health and Human Services (HHS) should take steps to fill the knowledge gaps in the capability of the private and public sectors to produce, distribute, and administer vaccines and antiviral drugs to various population groups to control the spread and effect of a pandemic. Specifically, HHS should, if existing surge capacity is insufficient, work with manufacturers to determine the investment and time required to expand production capacity, or the feasibility of creating a stockpile against projected shortages.

Agency Affected: Department of Health and Human Services

Status: Closed - Implemented

Comments: GAO recommended that HHS identify the capability of all manufacturers to produce antiviral drugs and pneumococcal vaccines and their existing surge capacity to expand production as needed during a pandemic. In response, HHS published a Pandemic Influenza Implementation Plan in November 2006. This plan recognizes that pharmaceutical manufacturing production surge capacity is an integral component of the HHS Pandemic Influenza Implementation Plan. HHS has invested heavily in enhancing domestic vaccine manufacturing capacity, including more than $1 billion in May 2006 for exploring alternative methods of vaccine production, such as cell-culture technology. HHS has also facilitated the expansion of domestic antiviral drug manufacturing capacity. In March 2006, HHS dedicated $200 million for the development of antiviral drugs, and in January 2007, awarded $103 million for advanced research on a new antiviral drug. Also, HHS is working to identify mechanisms to permit other manufacturers to produce proprietary antiviral drugs, including the potential for sub-licensure from manufacturers of approved drugs.

Recommendation: To improve the nation's ability to respond to the emergence of a pandemic influenza virus and help ensure an adequate and appropriate level of public protection, the Secretary of Health and Human Services (HHS) should take steps to fill the knowledge gaps in the capability of the private and public sectors to produce, distribute, and administer vaccines and antiviral drugs to various population groups to control the spread and effect of a pandemic. Specifically, HHS should identify the capability of all manufacturers to produce antiviral drugs and pneumococcal vaccines and their existing surge capacity to expand production as needed during a pandemic.

Agency Affected: Department of Health and Human Services

Status: Closed - Implemented

Comments: GAO recommended that HHS explore and evaluate alternative methods to produce and distribute influenza vaccine and strategies to help quickly identify newly detected strains of the influenza virus. In response, HHS has engaged in preparedness activities that support the larger national effort to prepare for pandemic influenza. HHS's key strategies for pandemic influenza preparedness focus on international activities; domestic surveillance; public health interventions; medical response; vaccine and antiviral drugs; communication; and support for state, local, and tribal preparedness. One major area of focus is building vaccine production capacity and vaccine supply. HHS has substantially completed this recommendation by investing more than $5 billion in domestic vaccine manufacturing capacity, including more than $1 billion in May 2006 for exploring alternative methods of vaccine production, such as cell-culture technology. HHS has developed plans for the distribution of vaccine and antivirals during a pandemic, including building stockpiles overseas in an attempt to contain a potential pandemic outbreak. HHS has also addressed the recommendation to develop strategies to quickly identify new detected strains of the influenza virus. HHS is engaged in a number of international efforts. For example, HHS is actively supporting an international effort to collect influenza virus samples from infected animals and making them available in the public domain for the benefit of research and development. Increased animal surveillance could speed the diagnosis and reporting of novel influenza strains.

Recommendation: To improve the nation's ability to respond to the emergence of a pandemic influenza virus and help ensure an adequate and appropriate level of public protection, the Secretary of Health and Human Services (HHS) should take steps to fill the knowledge gaps in the capability of the private and public sectors to produce, distribute, and administer vaccines and antiviral drugs to various population groups to control the spread and effect of a pandemic. Specifically, HHS should explore and evaluate alternative methods to produce and distribute influenza vaccine and strategies to help quickly identify newly detected strains of the influenza virus.

Agency Affected: Department of Health and Human Services

Status: Closed - Implemented

Comments: In a 2000 report on federal and state response efforts for pandemic influenza, GAO recommended that the Secretary of the Department of Health and Human Services (HHS) establish a deadline for completing and publishing a federal response plan that will address how private and public sector responsibilities might change during a pandemic for the purchase, use, and distribution of influenza and pneumococcal vaccines and antiviral drugs. In response, HHS developed a HHS Pandemic Influenza Implementation Plan, first published in November 2006 that include vaccine regulatory guidelines discussing regulatory approaches which may be utilized in the event of a pandemic, including investigational new drug usage, emergency use authorization, and licensure. According to HHS, upon receipt of a pandemic declaration, HHS will select a pandemic virus isolate for virus reference strain production and ship to vaccine manufacturers. For any expedited development or access, HHS cautions that early and frequent interactions between the vaccine manufacturer (public or private) and the FDA are of the highest importance. To accelerate the transition of medical countermeasures to pandemic influenza during a pandemic, HHS reported that as of April 2007, it was developing a web-based road-map for obtaining needed information for the efficient submission of high quality investigational drug applications, emergency use authorizations and biologics license applications. FDA may sanction emergency use authorizations only after a declaration of emergency from the HHS Secretary and if certain legal requirements are met. Also, although HHS has taken several steps in distribution of antivirals and vaccines for a pandemic, HHS officials told us in July/August 2006 that they currently have no plans to utilize pneumoccocal vaccines as a pharmaceutical countermeasure for a pandemic.

Recommendation: The Secretary of Health and Human Services should establish a deadline for completing and publishing a federal response plan that will address how private and public sector responsibilities might change during a pandemic for the purchase, use, and distribution of influenza and pneumococcal vaccines and antiviral drugs.